Mycamine — Class II drug recall D-0548-2018
Terminated recall by Astellas Pharma US Inc, reported 2018-02-14, distributed nationwide. Labeling: Label Error on Declared Strength
| Recall number | D-0548-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Astellas Pharma US Inc, Northbrook, IL, United States |
| Recall initiated | 2018-01-22 |
| Classified | 2018-02-27 |
| Reported by FDA | 2018-02-14 |
| Terminated | 2019-05-01 |
| Distributed | Nationwide (US) |
| Quantity | 63,600 vials |
| Reason classes | labeling, potency |
| NDC | 00469-3211, 00469-3211-10, 00469-3250, 00469-3250-10 |
| Lot numbers | 02/20, 06/20, A000000220, F1700164 |
Product
Mycamine (micafungin) for Injection 100 mg/vial Single-Dose Vial Rx only Marketed by: Astellas Pharma US, Inc. Northbrook, IL 60062, NDC 0469-3211-10
Reason for recall
Labeling: Label Error on Declared Strength
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0548-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.